Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
- Conditions
- Ovarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00017303
- Lead Sponsor
- Cytran
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.
- Detailed Description
OBJECTIVES: I. Determine the complete pathologic response rate at second-look surgery in patients with optimally resected stage III ovarian epithelial or primary peritoneal cancer treated with adjuvant paclitaxel, carboplatin, and IM-862. II. Determine the safety profile of this regimen in this patient population. III. Determine the incidence of infectious and hematologic complications in patients treated with this regimen. IV. Determine the progression-free survival of patients with no disease or minimal disease burden after initial therapy, when treated with IM-862 consolidation therapy. V. Correlate angiogenesis markers and immunologic parameters with response in patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of three IM-862 doses. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with IM-862 begins within 10 days of chemotherapy initiation and continues until clinical evidence of disease progression or until 3 days before second-look surgery. Arm I: Patients receive a low-dose of IM-862 and 2 placebo doses intranasally daily. Arm II: Patients receive a medium-dose of IM-862 and 2 placebo doses as in arm I. Arm III: Patients receive higher-dose IM-862 intranasally three times daily. Patients undergo second-look surgery within 4-8 weeks after completion of the last course of chemotherapy. Patients with a complete pathologic response or only microscopically detectable residual disease receive consolidation therapy with IM-862, according to their original treatment arm. Consolidation therapy begins within 3-14 days after second-look surgery and continues for 24 weeks in the absence of disease progression. Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 180 patients (60 per arm) will be accrued for this study within 1 year.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
University of Kansas School of Medicine-Wichita
🇺🇸Wichita, Kansas, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Comprehensive Cancer Center
🇺🇸Glendale, California, United States
Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Community Hospital of Los Gatos
🇺🇸Los Gatos, California, United States
University of Washington School of Medicine
🇺🇸Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Fletcher Allen Health Care - Medical Center Campus
🇺🇸Burlington, Vermont, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Women's Cancer Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States